Effectiveness, Safety, and Tolerability of Analgesics in the Prevention of Chronic Migraine

Last updated: July 5, 2021
Sponsor: Peking University Third Hospital
Overall Status: Completed

Phase

3

Condition

Migraine (Pediatric)

Oral Facial Pain

Migraine And Cluster Headaches

Treatment

N/A

Clinical Study ID

NCT04961671
D2019119
  • Ages 18-80
  • All Genders

Study Summary

Study Objectives:

To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AIM-D is a PRO assessment scale with nine items that is used to assess the impact ofmigraine on the ability to perform daily activities And a decline in bodily function.Subjects were asked to use a six-point rating scale ranging from "not difficult atall", "somewhat difficult", "slightly difficult", "very difficult", "very difficult"to "not complete at all" to rate daily activities (such as household chores, businesstrips, family leisure activities, leisure or social activities outside the home,drama, etc.) completed within the last 24 hours Difficulty with vigorous physicalactivity) and reduced physical function (e.g. difficulty walking, moving the body,bending forward, shaking head) Rate the difficulty you encounter. Some items includedthe answer "I don't have..." ", for example: "I have no plan On a business trip.

Exclusion

Exclusion Criteria:

  • Difficulty distinguishing migraine headaches from tension-type or other headaches
  • Has a history of migraine, accompanied by diplopia or decreased level ofconsciousness, or retinal migraine as defined by ICHD-3, 2018 3. Has a currentdiagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg,cluster headache), or painful cranial neuropathy as defined by ICHD- - History of aninadequate response to> 4 medications (2 of which have different mechanisms of action)prescribed for the prevention of migraine (see to Section 12.3)
  • Currently taking more than I medication with demonstrated efficacy for the preventionof migraine OR participants who are taking 1 migraine prevention medication, but inthe opinion of the investigator: the dose has not been stable and/or the medicationhas not been well-tolerated for at least 12 weeks prior to Visit I the participant isnot willing or able to maintain taking this medication at a stable dose and dosageregimen throughout the study

Study Design

Total Participants: 750
Study Start date:
December 01, 2019
Estimated Completion Date:
May 01, 2021

Study Description

Study Objectives:

To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM. Clinical Hypotheses: In participants with CM, at least one of the following atogepant doses (30 mg BID and 60 mg once daily) is superior to placebo as measured by the change from baseline in mean monthly migraine days across the 12-week treatment period. Atogepant has an acceptable safety and tolerability profile in participants with CM.

Study Design Structure: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study Duration: The study will consist of a 4-week screening and baseline period, a 12-week double-blind treatment period, and a follow-up period of 4 additional weeks, for a total duration of20 weeks Study Intervention: Atogepant 30 mg BID and 60 mg once daily tablets Control: Atogepant-matching placebo Dosage/Dose Regimen: Atogepant 30 mg BID, atogepant 60 mg once daily, and placebo will be administered for 12 weeks duration.

Randomization/Stratification:

Approximately 750 participants will be randomized to I of 3 treatment arms in a I: I: I ratio as follows:

  • Placebo (n = 250)

  • Atogepant 30 mg BID (n = 250) C • Atogepant 60 mg once daily (n = 250)

Connect with a study center

  • Allergan Limited I" Floor Marlow International, The Parkway Marlow, Buckinghamshire SL7 IYL United Kingdom

    Beijing,
    China

    Site Not Available

  • Peking Yniversity Third Hospital

    Beijing,
    China

    Site Not Available

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